U.S. patent number 5,954,635 [Application Number 08/920,990] was granted by the patent office on 1999-09-21 for devices and methods for percutaneous surgery.
This patent grant is currently assigned to SDGI Holdings Inc.. Invention is credited to John B. Clayton, Kevin Thomas Foley, Joseph Moctezuma, Maurice Mell Smith.
United States Patent |
5,954,635 |
Foley , et al. |
September 21, 1999 |
Devices and methods for percutaneous surgery
Abstract
Devices and methods for performing percutaneous spinal surgery
under direct visualization and through a single cannula are shown.
A device (10) is provided which includes an elongated cannula (20)
having a first inner diameter (D.sub.I) and an outer diameter
(D.sub.O) sized for percutaneous introduction into a patient. The
cannula (20) defines a working channel (25) between its ends (21,
22) which has a second diameter (D.sub.2) equal to the diameter
(D.sub.I) of the cannula sized for receiving a tool therethrough.
An elongated viewing element (50) is engageable to the cannula (20)
adjacent the working channel (25), preferably by a fixture (30).
The fixture (30) includes a housing (31) attachable to the proximal
end (22) of the cannula (20) that defines a working channel opening
(35) which is in communication with the working channel (25). The
housing (31) also defines an optics bore (60) adjacent the working
channel opening (35). In certain embodiments, the fixture (30)
supports the viewing element (50) for translation and/or rotation
within the optics bore (60) along the longitudinal axis of the
bore, and for rotation of the housing (31) relative to the cannula
(20) so that the longitudinal axis of the optics bore (60) will
rotate about the longitudinal axis of the working channel (25).
Methods are also provided for performing spinal surgeries
percutaneously with direct visualization and without the
requirement for a fluid-maintained workspace.
Inventors: |
Foley; Kevin Thomas
(Germantown, TN), Smith; Maurice Mell (Cordova, TN),
Clayton; John B. (Germantown, TN), Moctezuma; Joseph
(Memphis, TN) |
Assignee: |
SDGI Holdings Inc. (Wilmington,
DE)
|
Family
ID: |
24488004 |
Appl.
No.: |
08/920,990 |
Filed: |
August 29, 1997 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
|
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620933 |
Mar 22, 1996 |
|
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Current U.S.
Class: |
600/114; 600/102;
604/264 |
Current CPC
Class: |
A61M
29/02 (20130101); A61M 29/00 (20130101); A61B
17/3417 (20130101); A61B 17/02 (20130101); A61B
2017/347 (20130101); A61B 90/50 (20160201); A61B
2090/306 (20160201); A61B 17/1671 (20130101); A61B
17/3421 (20130101); A61B 2017/00469 (20130101); A61B
2017/00296 (20130101); A61B 2017/0046 (20130101); A61B
2017/00261 (20130101); A61B 2017/0262 (20130101); A61B
2090/3614 (20160201); A61B 2017/3445 (20130101); A61B
2090/373 (20160201) |
Current International
Class: |
A61B
17/34 (20060101); A61M 29/00 (20060101); A61B
17/16 (20060101); A61B 19/00 (20060101); A61B
17/00 (20060101); A61B 001/04 () |
Field of
Search: |
;600/102,114,171
;604/264,164,167,169 |
References Cited
[Referenced By]
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Foreign Patent Documents
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EP |
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FR |
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WO |
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WO95/22285 |
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Aug 1995 |
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WO |
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Other References
Laparoscopic Bone Dowel Surgical Technique Sofamor Danek The Spine
Specialist. .
Spinal Endoscopy, Evolution, Applications & Foundations,
Hallett H. Mathews, M.D. .
Laparoscopic Bone Dowel Instruments Brochure, Sofamor Danek 1995.
.
Micro Endo Systems Brochure, Sofamor Danek 1994..
|
Primary Examiner: Flanagan; Beverly M.
Attorney, Agent or Firm: Woodard, Emhardt, Naughton Moriarty
& McNett Patent and Trademark Attorneys
Parent Case Text
This application is a division of application Ser. No. 08/620,933,
filed Mar. 22, 1996.
Claims
What is claimed:
1. The method for performing a surgical procedure at a location in
a patient's body, comprising the steps of:
creating a working channel through the skin and tissue of a
patient;
creating a working space in communication with the working channel
and adjacent the location in the patient's body;
inserting optics through the working channel to the working
space;
extending a first tool through the working channel to the working
space with the optics in the working channel; and
manipulating the first tool through the working channel to perform
a surgical procedure on the location in the working space under
direct vision from the optics and without directing irrigation
fluid to the location.
2. The method of claim 1 wherein the tool is a power drill and the
surgical procedure is drilling through bone or tissue at the
location.
3. The method of claim 1, further comprising the steps of:
extending the optics through the working channel beyond the end of
the working channel adjacent the working space for direct
visualization of the working space and manipulating the tool.
4. The method of claim 1, further comprising the steps of:
removably inserting a second tool through the working channel
simultaneous with the first tool; and
manipulating the second tool to perform a function at the
location.
5. The method of claim 4 further comprising the steps of:
inserting a guidewire into a patient through skin and tissue to the
location;
inserting a cannulated dilator over the guidewire and through the
skin and tissue to the location; inserting a cannula over the
dilator;
removing the guidewire after inserting the dilator; and
removing the dilator after inserting the cannula.
6. The method for performing a surgical procedure of claim 1,
wherein the step of creating a working channel includes:
inserting a first dilator through the skin and tissue of the
patient;
sequentially inserting at least one more dilator over the first
dilator;
inserting a cannula over the last inserted dilator; and
then removing the dilators so that the cannula defines the working
channel.
7. A method for performing a surgical procedure at a location on
the spine, comprising the steps of:
creating a working channel through the skin and tissue of a
patient;
creating a working space in communication with the working channel
and adjacent the location on the spine;
extending a tool through the working channel beyond the end of the
working channel and manipulating the tool in the working space;
and
placing optics through the working channel with the tool in the
working channel, the optics extending beyond the end of the working
channel adjacent the working space to directly visualize the
working space and manipulation of the tool.
8. The method for performing a surgical procedure of claim 7
wherein the step of creating a working channel includes:
inserting a first dilator through the skin and tissue of the
patient;
sequentially inserting at least one more dilator over the first
dilator;
inserting a cannula over the last inserted dilator; and
then removing the dilators so that the cannula defines the working
channel.
9. A method for performing a surgical procedure at a location on
the spine, comprising the step of:
creating a working channel through the skin and tissue of a
patient;
creating a working space in communication with the working channel
and adjacent the location on the spine;
removably inserting a first tool through the working channel;
manipulating the first tool to perform a function at the
location;
removably inserting a second tool through the working channel
simultaneous with the first tool; and
manipulating the second tool to perform a function at the
location.
10. A method for performing a surgical procedure at a location on
the spine, comprising the steps of:
creating a working channel through the skin and tissue of a
patient;
creating a working space in communication with the working channel
and adjacent the location on the spine;
removably inserting a first tool through the working channel
wherein the first tool is a tissue retractor;
manipulating the tissue retractor to retract tissue to maintain the
working space;
removably inserting a second tool through the working channel
simultaneous with the first tool; and
manipulating the second tool to perform a function at the
location.
11. A method for performing a discectomy at a subject vertebral
level on the spine, comprising the steps of:
creating an incision in the skin substantially directly posterior
to the subject vertebral level;
creating a bore through the lamina at a posterior medial position
on the spine;
mounting a cannula through the incision at the bore in the lamina
to create a working channel;
inserting optics through the cannula to directly visualize the
location on the spine beyond the end of the cannula;
extending a retractor through the working channel to retract tissue
to create a path to the spinal disc;
extending the optics through the working channel and path to the
spinal disc; and
extending and manipulating discectomy instruments through the
working channel to the disc to perform a discectomy under direct
vision by the optics.
12. The method of claim 11 wherein the step of creating a bore
includes conducting a laminectomy comprising the steps of:
inserting a cannula into the incision and through tissue to the
lamina to define a working channel;
extending optics through the working channel to directly visualize
the lamina; and
extending a bone cutting tool through the working channel and
manipulating the tool to perform a laminectomy under direct vision
from the optics.
13. A method for performing a laminectomy, comprising the steps
of:
creating an incision in the skin substantially directly posterior
to the subject vertebral level;
inserting a cannula into the incision and through tissue to the
lamina to define a working channel;
extending optics through the working channel to directly visualize
the lamina; and
extending a bone cutting tool through the working channel
simultaneous with the optics and manipulating the tool to perform a
laminectomy under direct vision from the optics.
14. The method for performing a laminectomy of claim 13, wherein
the step of inserting a cannula includes:
inserting a first dilator into the incision and through tissue to
the lamina;
sequentially inserting at least one more dilator over the first
dilator;
inserting the cannula over the last inserted dilator; and
then removing the dilators.
15. A method for implanting a vertebral fixation element,
comprising the steps of:
making an incision in the skin to provide access to the location on
the vertebra at which the fixation element is to be implanted;
inserting a cannula into the incision and through tissue to the
location to define a working channel;
inserting optics through the cannula to directly visualize the
location;
extending an insertion tool supporting the vertebral fixation
element through the working channel to the location under direct
vision; and
manipulating the insertion tool to implant the fixation element at
the location under direct vision from the optics.
16. The method of claim 15, wherein the vertebral fixation element
is a bone screw.
17. A method for performing a surgical procedure at a location in a
patient's body, comprising the steps of:
creating a working channel through the skin and tissue of a
patient;
creating a working space in communication with the working channel
and adjacent the location in the patient's body;
inserting optics through the working channel to the working
space;
extending a first tool through the working channel to the working
space wherein the first tool is a power tool;
manipulating the first tool through the working channel to perform
a surgical procedure on the location in the working space under
direct vision from the optics and without directing irrigation
fluid to the location; and
providing aspiration at the working space to remove smoke generated
by operation of the power tool.
18. A method for performing a surgical procedure at a location in a
patient's body, comprising the steps of:
creating a working channel through the skin and tissue of a patient
by inserting a cannula into the patient, the cannula having an
inner dimension defining the working channel;
creating a working space in communication with the working channel
and adjacent the location in the patient's body;
inserting optics through the working channel to the working
space;
extending a first tool through the working channel to the working
space; and
manipulating the first tool through the working channel to perform
a surgical procedure on the location in the working space under
direct vision from the optics and without directing irrigation
fluid to the location.
19. A method for performing a surgical procedure at a location on
the spine, comprising the steps of:
creating a working channel through the skin and tissue of a patient
by inserting a cannula into the patient, the cannula having an
inner dimension defining the working channel;
creating a working space in communication with the working channel
and adjacent the location on the spine;
extending a tool through the working channel beyond the end of the
working channel and manipulating the tool in the working space;
and
extending optics through the working channel beyond the end of the
working channel adjacent the working space to directly visualize
the working space and manipulation of the tool.
20. A method for performing a surgical procedure at a location on
the spine, comprising the steps of:
creating a working channel through the skin and tissue of a patient
by inserting a cannula into the patient, the cannula having an
inner dimension defining the working channel;
creating a working space in communication with the working channel
and adjacent the location on the spine;
removably inserting a first tool through the working channel;
manipulating the first tool to perform a function at the
location;
removably inserting a second tool through the working channel
simultaneous with the first tool; and
manipulating the second tool to perform a function at the
location.
21. A method for performing a surgical procedure at a location in a
patient's body, comprising the steps of:
creating a working channel through the skin and tissue of a
patient;
creating a working space in communication with the working channel
and adjacent the location in the patiant's body;
extending a first tool through the working channel to the working
space; and
manipulating the first tool through the working channel to perform
a surgical procedure on the location in the working space without
directing irrigation fluid to the location.
22. The method of claim 21, wherein the tool is a power drill and
the surgical procedure is drilling through bone or tissue at the
location.
23. The method of claim 21, further comprising the steps of:
removably inserting a second tool through the working channel
simultaneous with the first tool; and
manipulating the second tool to perform a function at the
location.
24. The method of claim 21, wherein said step of creating a working
channel includes inserting a cannula into the patient, the cannula
having an inner dimension defining the working channel.
25. The method for performing a surgical procedure of claim 21,
wherein the step of creating a working channel includes:
inserting a first dilator into the incision and through tissue to
the lamina;
sequentially inserting at least one more dilator over the first
dilator;
inserting a cannula over the last inserted dilator; and
then removing the dilators so that the cannula defines a working
channel.
26. A method for preparing a working channel adjacent the spine,
comprising the steps of:
inserting a guidewire through an incision in the skin and into the
lamina of a vertebra;
inserting a first dilator over the guidewire and through the
incision into contact with the lamina;
removing the guidewire;
sequentially inserting dilators of increasing diameter over the
first and subsequent dilators, each of the dilators having a
tapered working end configured to atraumatically displace
tissue;
advancing a cannula over the last inserted dilator, the cannula
having a distal end adjacent the lamina and an opposite proximal
end; and
then removing the dilators so that the cannula defines a working
channel.
27. The method of claim 26, further comprising the step of affixing
to the cannula a mounting bracket having a flexible arm
support.
28. The method of claim 27, wherein the flexible arm support is
contoured.
29. The method of claim 26, further comprising the step of
advancing a fixture over the proximal end of the cannula for
supporting a viewing element adjacent the working channel.
30. A method for implantation of at least one fusion device in a
disc space between adjacent vertebrae, comprising the steps of:
making an incision in the skin to provide access to the disc space
where the fusion device is to be implanted,;
inserting a cannula into the incision and through the tissue to the
location to define a working channel to the disc space;
inserting optics through the cannula to directly visualize the disc
space;
preparing the disc space through the working channel under direct
vision from the optics for implantation of at least one fusion
device; and
advancing the fusion device through the working channel into the
prepared disc space under direct vision from the optics.
31. The method of claim 30, wherein the fusion device is a bone
dowel.
32. The method of claim 30, wherein the fusion device is a push-in
implant.
33. The method of claim 30, wherein the fusion device is a threaded
implant.
34. The method of claim 30, wherein the fusion device is graft
material.
Description
FIELD OF THE INVENTION
The present invention relates to devices, instruments and methods
for performing percutaneous surgeries, particularly at locations
deep within the body. One specific application of the invention
concern devices, instruments and techniques for percutaneous,
minimally invasive spinal surgery. In another aspect of the
invention, the percutaneous surgery is performed under direct
vision at any location in the body.
BACKGROUND OF THE INVENTION
Traditional surgical procedures for pathologies located deep within
the body can cause significant trauma to the intervening tissues.
These open procedures often require a long incision, extensive
muscle stripping, prolonged retraction of tissues, denervation and
devascularization of tissue. Most of these surgeries require a
recovery room time of several hours and several weeks of
post-operative recovery time due to the use of general anesthesia
and the destruction of tissue during the surgical procedure. In
some cases, these invasive procedures lead to permanent scarring
and pain that can be more severe than the pain leading to the
surgical intervention.
Minimally invasive alternatives such as arthroscopic techniques
reduce pain, post-operative recovery time and the destruction of
healthy tissue. Orthopedic surgical patients have particularly
benefitted from minimally invasive surgical techniques. The site of
pathology is accessed through portals rather than through a
significant incision thus preserving the integrity of the
intervening tissues. These minimally invasive techniques also often
require only local anesthesia. The avoidance of general anesthesia
reduces post-operative recovery time and the risk of
complications.
Minimally invasive surgical techniques are particularly desirable
for spinal and neurosurgical applications because of the need for
access to locations deep within the body and the danger of damage
to vital intervening tissues. For example, a common open procedure
for disc herniation, laminectomy followed by discectomy requires
stripping or dissection of the major muscles of the back to expose
the spine. In a posterior approach, tissue including spinal nerves
and blood vessels around the dural sac, ligaments and muscle must
be retracted to clear a channel from the skin to the disc. These
procedures normally take at least one-two hours to perform under
general anesthesia and require post-operative recovery periods of
at least several weeks. In addition to the long recovery time, the
destruction of tissue is a major disadvantage of open spinal
procedures. This aspect of open procedures is even more invasive
when the discectomy is accompanied by fusion of the adjacent
vertebrae. Many patients are reluctant to seek surgery as a
solution to pain caused by herniated discs and other spinal
conditions because of the severe pain sometimes associated with the
muscle dissection.
In order to reduce the post-operative recovery time and pain
associated with spinal and other procedures, micro-surigical
techniques have been developed. For example, in micro-surgical
discectomies, the disc is accessed by cutting a channel from the
surface of the patient's back to the disc through a small incision.
An operating microscope or loupes is used to visualize the surgical
field. Small diameter micro-surgical instruments are passed through
the small incision and between two laminae and into the disc. The
intervening tissues are disrupted less because the incision is
smaller. Although these micro-surgical procedures are less
invasive, they still involve some of the same complications
associated with open procedures, such as injury to the nerve root
and dural sac, perineural scar formation, reherniation at the
surgical site and instability due to excess bone removal.
Other attempts have been made for minimally invasive procedures to
correct symptomatic spinal conditions. One example is
chemonucleolysis which involved the injection of an enzyme into the
disc to partially dissolve the nucleus to alleviate disc
herniation. Unfortunately, the enzyme, chymopapain, has been
plagued by concerns about both its effectiveness and complications
such as severe spasms, post-operative pain and sensitivity
reactions including anaphylactic shock.
The development of percutaneous spinal procedures has yielded a
major improvement in reducing recovery time and post-operative pain
because they require minimal, if any, muscle dissection and they
can be performed under local anesthesia. For example, U.S. Pat. No.
4,545,374 to Jacobson discloses a percutaneous lumbar discectomy
using a lateral approach, preferably under fluoroscopic X-ray. This
procedure is limited because it does not provide direct
visualization of the discectomy site.
Other procedures have been developed which include arthroscopic
visualization of the spine and intervening structures. U.S. Pat.
Nos. 4,573,448 and 5,395,317 to Kambin disclose percutaneous
decompression of herniated discs with a posterolateral approach.
Fragments of the herniated disc are evacuated through a cannula
positioned against the annulus. The '317 Kambin patent discloses a
biportal procedure which involves percutaneously placing both a
working cannula and a visualization cannula for an endoscope. This
procedure allows simultaneous visualization and suction, irrigation
and resection in disc procedures.
Unfortunately, disadvantages remain with these procedures and the
accompanying tools because they are limited to a specific
application or approach. For example, Jacobson, Kambin and other
references require a lateral or a posterolateral approach for
percutaneous discectomy. These approaches seek to avoid damage to
soft tissue structures and the need for bone removal because it was
thought to be impractical to cut and remove bone through a channel.
However, these approaches do not address other spinal conditions
which may require a mid-line approach, removal of bone or
implants.
U.S. Pat. No. 5,439,464 to Shapiro discloses a method and
instruments for performing arthroscopic spinal surgeries such as
laminectomies and fusions with a mid-line or medial posterior
approach using three cannulas. Each of the cannulas requires a
separate incision. While Shapiro discloses an improvement over
prior procedures which were limited to a posterolateral or lateral
approach for disc work, Shapiro's procedure still suffers from many
of the disadvantages of known prior percutaneous spinal surgery
techniques and tools. One disadvantage of the Shapiro procedure is
its requirement of a fluid working space. Another significant
detriment is that the procedure requires multiple portals into the
patient.
Fluid is required in these prior procedures to maintain the working
space for proper function of optics fixed within a prior art
cannula and inserted percutaneously. Irrigation, or the
introduction of fluid into the working space, can often be
logistically disadvantageous and even dangerous to the patient for
several reasons. The introduction of fluid into the working space
makes hemostasis more difficult and may damage surrounding tissue.
Excess fluid may dangerously dilute the sodium concentration of the
patient's blood supply which can cause seizures or worse. The fluid
environment can also make drilling difficult due to cavitation. The
requirement for a fluid environment generally increases expenses
associated with the surgery and adds to the complexity of the
surgery, due in part to the relatively high volume of fluid
required.
A need has remained for devices and methods that provide for
percutaneous minimally invasive surgery for all applications and
approaches. A need has also remained for percutaneous methods and
devices which do not require a fluid-filled working space, but that
can be adapted to a fluid environment if necessary.
A significant need is present in this field for techniques and
instruments that permit surgical procedures in the working space
under direct vision. Procedures that reduce the number of entries
into the patient are also highly desirable. The fields of spinal
and neuro surgery have particularly sought devices and techniques
that minimize the invasion into the patient and that are
streamlined and concise in their application.
SUMMARY OF THE INVENTION
Briefly describing one aspect of the invention, there is provided
devices and method for performing percutaneous procedures under
direct visualization, even at locations deep within a patient. In
one embodiment, a device for use in percutaneous surgery includes
an elongated cannula having a first inner diameter and an outer
diameter sized for percutaneous introduction into a patient. The
cannula further includes a distal working end and an opposite
proximal end and defines a working channel between the ends having
a second diameter which is equal to the first inner diameter. The
working channel is sized to receive a tool therethrough. The device
also includes an elongated viewing element mounted inside the
cannula adjacent the working channel. The viewing element has a
first end connectable to a viewing apparatus and an opposite second
end disposed adjacent the distal working end of the cannula.
In another aspect, a fixture is provided for mounting the elongated
viewing element to the cannula. The fixture includes a housing
attachable to the proximal end of the cannula. The housing defines
a working channel opening therethrough in communication with the
working channel. The working channel opening is sized to
substantially correspond to the second diameter of the working
channel. The housing also defines an optics bore adjacent the
working channel opening. The optics bore is sized to receive the
elongated viewing element therethrough.
In some embodiments, the fixture supports the viewing device for
movement within the optics bore along the longitudinal axis of the
bore to extend or retract the lens relative to the distal working
end of the cannula. In other embodiments, the fixture supports the
viewing device for rotation within the optics bore about the
longitudinal axis of the bore. In some embodiments, the housing is
rotatable relative to the cannula so that the longitudinal axis of
the optics bore is rotatable about the longitudinal axis of the
working channel.
Novel tools are also provided which are insertable into the working
channel of the cannula. A tissue retractor in one embodiment
includes a body and an integral working tip configured to
atraumatically displace tissue as the retractor is manipulated
through tissue. The body has a convex surface configured to conform
to the inner cylindrical surface of the cannula and an opposite
concave surface which does not obstruct the working channel or
visualization of the working space. Cannulated tissue dilators are
also provided which are insertable over a guidewire or another
dilator as well as insertable into the working channel. In some
embodiments, the tissue dilators include a tapered working end to
displace tissue and a gripping portion having a number of
circumferential grooves to enhance gripping and manipulation of the
dilator.
According to the methods of this invention, spinal and other
surgeries can be performed percutaneously with direct visualization
without the requirement for a fluid-maintained working space. In
another aspect of the inventive surgical techniques, all steps of a
surgical procedure are conducted under direct vision through a
single working channel cannula. An optical scope or viewing device
is moved within the working channel and throughout the working
space from a variety of angles and orientations to provide a clear
view of the operative steps.
The techniques of the present invention also encompass passing
multiple tools and instruments through the single working channel
cannula and manipulating the instruments and tools within the
working space. In one specific embodiment, a tissue retractor is
provided that extends through the working channel without
significantly reducing the dimensions of the channel.
It is an object of the invention to provide devices and methods for
percutaneous spinal surgery for all applications and approaches.
One advantage of this invention is that percutaneous procedures can
be accomplished in a dry environment because a fluid working space
is not required for the proper function of the optics. One benefit
of this invention is that it provides instruments and methods which
reduce the cost, risk, pain and recovery time associated with
surgery. These and other objects, advantages and features are
accomplished according to the devices and methods of the present
invention.
DESCRIPTION OF THE FIGURES
FIG. 1 is a side elevational view of a device according to this
invention.
FIG. 2 is a top elevational view of a fixture for supporting a
viewing device within a cannula according to this invention.
FIG. 3 is a side cross-sectional view of the fixture shown in FIG.
2.
FIG. 4 is a side elevational view of a retractor according to one
embodiment of this invention.
FIG. 4A is an end cross-sectional view of the retractor of FIG. 4
taken along lines A--A.
FIG. 5 is a top elevational view of the retractor shown in FIG.
4.
FIG. 6 is an end elevational view of the retractor shown in FIGS. 4
and 5.
FIG. 7 is a side elevational view of a retractor according to
another embodiment of this invention.
FIG. 7A is an end cross-sectional view of the retractor of FIG. 7
taken along lines A--A.
FIG. 7B is an end cross-sectional view of the retractor of FIG. 7
taken along lines B--B.
FIG. 8 is a top elevational view of the retractor shown in FIG.
7.
FIG. 9 is a side elevational view of a dilator according to this
invention.
FIG. 10 (a)-(i) depicts the steps of a method according to this
invention.
FIG. 11 is a side cross-sectional view of a device according to one
embodiment of this invention.
FIG. 12 is a side cross-sectional view of an aspiration cap as
shown in FIG. 11.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
For the purposes of promoting an understanding of the principles of
the invention, reference will now be made to the embodiments
illustrated in the drawings and specific language will be used to
describe the same. It will nevertheless be understood that no
limitation of the scope of the invention is thereby intended, such
alterations and further modifications in the illustrated devices
and described methods, and such further applications of the
principles of the invention as illustrated therein being
contemplated as would normally occur to one skilled in the art to
which the invention relates.
The present invention provides instruments and methods for
performing percutaneous surgery, including spinal applications such
as laminotomy, laminectomy, foramenotomy, facetectomy or
discectomy, with a single working channel endoscope. The present
inventors have discovered that many percutaneous surgeries may be
performed without a fluid workspace through the use of optics which
move independently of the cannula. The present invention
contemplates techniques and instruments that can be implemented
with or without a fluid environment.
This invention also brings the advantages of percutaneous
procedures to applications that previously required open surgery.
One advantage is based upon the further discovery that bone work
can be performed percutaneously through a large working channel.
Another advantage is realized in the use of a single portal within
the patient to perform a wide range of simultaneous procedures.
According to one embodiment of the present invention, as depicted
in FIG. 1, a device 10 is provided for use in percutaneous surgery
which includes an elongated cannula 20 having a first inner
diameter D.sub.I and an outer diameter D.sub.O sized for
percutaneous introduction into a patient. The cannula 20 also
includes a distal working end 21 and an opposite proximal end 22.
The cannula defines a working channel 25 between the ends 21, 22
having a second diameter d.sub.2 equal to the first inner diameter
D.sub.I sized for receiving a tool therethrough. The cannula has a
length along its longitudinal axis L that is sized to pass through
the patient from the skin to an operative site or working space. In
some cases, the working space may be adjacent a vertebra or disc,
or in the spinal canal.
An elongated viewing element 50 is mountable inside cannula 20
adjacent the working channel 25. The viewing element 50 has a first
end 51 connectable to a viewing apparatus, such as an eyepiece or
camera, and an opposite second end 52 disposed or positioneable
adjacent the distal working end 21 of the cannula 20. The
particular elongated viewing element 50 is not critical to the
invention. Any suitable viewing element is contemplated that
creates an optical or image transmission channel. In one
embodiment, the elongated viewing element 50 includes a fiber optic
scope 54 and a lens 55 at the second end 52. Preferably, the fiber
optic scope includes illumination fibers and image transmission
fibers (not shown). Alternatively, the viewing element may be a
rigid endoscope or an endoscope having a steerable or bendable
tip.
One advantage of this invention is that it provides optics which
are movable relative to the cannula 20. Because the optics are
movable, it is not necessary to provide a fluid-maintained work
space. The optics can be removed, cleaned and replaced while the
cannula is percutaneously positioned within the patient over the
working space. Any configuration which allows the optics to be
movably supported adjacent the working channel 25 is contemplated.
In one embodiment, shown in FIGS. 1-3, a fixture 30 is provided for
mounting the elongated viewing element 50 to the cannula 20.
Preferably, the fixture 30 includes a housing 31 attachable to the
proximal end 22 of the cannula 20. The working channel opening 35
is sized to substantially correspond to the second diameter d.sub.2
of the working channel 25 to receive tools. The fixture 30 includes
a housing 31 which defines a working channel opening 35 arranged to
communicate with the working channel 25 when the fixture 30 is
mounted to the cannula 20. The working channel opening 35 is sized
to receive tools therethrough for passage through the working
channel 25. In the embodiments shown in FIGS. 1-3, the fixture 30
is configured to mount the viewing element 50 within the working
channel 25.
The housing 31 also defines an optics bore 60 adjacent the working
channel opening 35. The optics bore 60 has a longitudinal axis that
is preferably substantially parallel to the axis L of the cannula
and working channel. The optics bore 60 is preferably sized to
removably receive the elongated viewing element 50 therethrough.
The fixture 30 preferably supports the viewing element 50 for
movement within the optics bore 60 along the longitudinal axis of
the bore 60 to extend or retract the lens 55 relative to the distal
working end 21 of the cannula 20. The retractable/extendable
feature of the optics of this invention provides an advantage over
prior endoscopes because it eliminates the requirement for a fluid
workspace. While the device 10 and its viewing element 50 can be
easily used in a fluid environment, the fluid is not essential for
the system to operate, contrary to prior systems. Furthermore, many
of the prior endoscopes were not suited to access certain areas
because of their large diameters. For example, prior endoscopes
could not access the spinal canal. However, with this invention,
access to the spinal canal is not limited by the diameter of the
channel or cannula. The cannula 20 can be left behind in the soft
tissue or supported by the lamina while the second end 52 of the
elongated viewing element 50 can be advanced into the spinal canal
along with any spinal instruments which have been inserted into the
working channel 25.
Preferably the fixture 30 also supports the viewing element 50 for
rotation within the optics bore 60 about the longitudinal axis of
the bore 60. The lens 55 of the viewing element 50 defines an
optical axis A.sub.O. As in many endoscopes, the optical axis
A.sub.O can be offset at an angle relative to the longitudinal axis
of the optics bore 60. This feature allows the optical axis A.sub.O
of the lens to be swept through a conical field of view F for
greater visibility of the working space. The fixture 30 can further
be configured so that the viewing element 50 is rotatable relative
to the cannula 20. In this embodiment, the housing 31 is rotatable
relative to the cannula 20 so that the second longitudinal axis of
the optics bore 60 rotates about the longitudinal axis L of the
working channel 25. The rotatable features of this invention allows
visualization of the entire working space. This feature also aids
in simplifying the surgical procedure because the optics 50 and
accompanying fittings can be moved out of the way of the surgeon's
hands and tools passing through the working channel.
In one embodiment depicted in FIG. 3, the housing 31 defines a
receiver bore 40 having an inner diameter d.sub.I slightly larger
than the outer diameter D.sub.O of the cannula 20. In this
configuration, the proximal end 22 of the cannula 20 can be
received within the receiver bore 40 so that the housing 31 can
rotate about the proximal end 22 of the cannula 20. As shown in
FIG. 3, the housing 31 also includes an upper bore 41 which is
contiguous with the working channel opening 35 and the receiver
bore 40. In one embodiment, the optics bore 60 is disposed within
the upper bore 41 of the housing 31.
In a preferred embodiment depicted in FIG. 2, the optics bore 60 is
defined by a C-shaped clip 61 disposed within the upper bore 41.
Preferably, the C-shaped clip 61 is formed of a resilient material
and the optics bore 60 defined by the clip 61 has an inner diameter
D.sub.i that is slightly less than the outer diameter of the
elongated viewing element 50. When the viewing element 50 is pushed
into the optics bore 60 it resiliently deflects the C-shaped clip
61. The resilience of the clip 61 provides a gripping force on the
element 50 to hold it in the desired position, while still allowing
the element 50 to be repositioned.
Alternatively, the optics bore 60 can have an inner diameter larger
than the outer diameter of the viewing element. In this instance,
the viewing element 50 can be supported outside the device 20,
either manually or by a separate support fixture.
Preferably the device 10 provides engagement means for securely yet
rotatably engaging the fixture 30 to the cannula 20. Most
preferably, the fixture 30 is configured to engage a standard
cannula 20. Engagement means can be disposed between the housing 31
and the cannula 20 when the fixture 30 is mounted to the proximal
end 22 of the cannula 20 for providing gripping engagement between
the housing 31 and the cannula 20. In one embodiment depicted in
FIG. 3 the engagement means includes a number of grooves 32 within
the receiver bore 40 and a resilient sealing member, such as an
O-ring (see FIG. 11) disposed in each groove 32. The sealing
members, or O-rings, disposed between the housing 31 and the outer
diameter D.sub.O of the cannula 20 rotatably secure the fixture 30
to the cannula 20. The O-rings provide sufficient resistance to
movement to hold the fixture 30 in a selectable position on the
cannula. In another embodiment, the housing 31 defines a receiver
bore 40 which has an inner diameter d.sub.I which is only slightly
larger than the outer diameter D.sub.O of the cannula 20 so that
the housing 31 can rotate freely about the cannula 20.
The working channel 25 and the working channel opening 35 are both
sized to receive a tool or instrument therethrough. Preferably, the
working channel opening 35 of the housing 31 has a diameter Dw
which is substantially equal to the inner diameter d.sub.2 of the
working channel 25 so that the effective diameter of the working
channel is not reduced by the fixture 30. This configuration
provides a maximum amount of space for the insertion of tools into
the working channel 25. The present invention is advantageous
because standard micro-surgical spinal tools can be inserted into
the working channel and manipulated to perform a surgical
procedure. The present invention is particularly advantageous
because the working channel 25 will simultaneously accept a
plurality of movable instruments. No other known prior art device
has a working channel that accepts more than one movable instrument
at a time through a single port. Therefore, according to this
invention, an entire percutaneous surgical procedure can be
performed through the working channel 25 of the device 10 under
direct visualization using the viewing element 50 disposed within
the optics bore 60.
Although standard micro-surgical instruments may be used with the
present invention, this invention also contemplates certain novel
tools which capitalize on and enhance the advantages of this
invention.
According to one preferred embodiment of the invention, a tissue
retractor 70 is provided as depicted in FIGS. 4-6. The retractor 70
is removably and rotatably insertable through the working channel
25 and the working channel opening 35 of the device 10. The tissue
retractor 70 includes a working tip 75 configured to atraumatically
displace tissue as the retractor 70 is manipulated through the
tissue and a body 76 having a proximal first end 77 and a distal
second end 78. The second end 78 can be integral with the working
tip 75 which preferably has a blunt curved end 82. In addition, the
working tip 75 is also preferably bent or curved away from the body
76, as shown in FIG. 7. The body 76 is sized to be rotatably
received within the cannula 20 and has a length B from the first
end 77 to the second end 78 sufficient so that the first end 77 and
the working tip 75 can both extend outside the cannula 20 when the
body 76 is within the cannula 20.
This invention contemplates any suitable retractor for use through
the working channel 25. However, retractors such as the retractor
70 depicted in FIGS. 4-6 are preferred in which the body 76
includes a curved plate 84 that is configured to conform to the
inner cylindrical surface 26 of the cannula without substantially
blocking the working channel 25. The curved plate 84 has a convex
surface 80 and an opposite concave surface 81. In one embodiment,
the curved plate 84 includes a first plate portion 85 defining a
first convex surface 80 and an opposite first concave surface 81. A
second plate portion 86 is integral with the first plate portion 85
and is disposed between the first plate portion 85 and the working
tip 75. The second plate portion 86 defines a second convex surface
(not shown) and an opposite second concave surface 81'. Both the
first plate portion 85 and the second plate portion 86 include
opposite edges 90 extending substantially parallel to the length B
of the body 76.
Preferably, the curved plate 84 subtends an arc A.sub.1 between the
opposite edges 90 of at least 200 degrees, and most preferably 270
degrees. In a specific embodiment, the second plate portion 86 and
specifically the second concave surface 81' subtends an angle that
decreases along the length of the retractor. Thus, in an
embodiment, the second concave surface 81' subtends an angle of
about 200 degrees adjacent the first plate portion 85, decreasing
to an angle of less than about 10 degrees at end 78.
An alternate embodiment of a tissue retractor according to this
invention is depicted in FIGS. 7-8. This retractor 100 has a body
106 which includes a first plate portion 115 defining a first
convex surface 110 and an opposite first concave surface 111 and
includes first opposite edges 120 extending substantially parallel
to the length B of the body 106. The first plate portion 115
subtends a first arc A.sub.2 between the first opposite edges 120.
The retractor body 106 also includes a second plate portion 116
which is integral with the first plate portion 115 and is disposed
between the first plate portion 115 and a working tip 105. The
second plate portion 116 defines a second convex surface 110' and
an opposite second concave surface 111' and includes second
opposite edges 120' extending substantially parallel to the length
B. The second plate portion 116 subtends a second arc A.sub.3
between the second opposite edges 120' that is different from the
first arc A.sub.2 in this embodiment. Preferably, the first arc
A.sub.2 subtends an angle of less than 180 degrees and the second
arc A.sub.3 subtends an angle of more than 180 degrees. Most
preferably, the first arc A.sub.2 subtends an angle of about 90
degrees and the second arc A.sub.3 subtends an angle of about 270
degrees.
The retractors of this invention may be provided with means for
engaging the retractors 70, 100 within the working channel 25 of
the cannula 20. For example, the convex surfaces 80, 110 can be
configured to have a diameter that is greater than the diameter
D.sub.I of the inner cylindrical surface 26 of the cannula 20. In
that case, the body 76, 106 may be formed of a resilient material
that is deformable to be insertable into the cannula 20 so that the
convex surface 80, 110 is in contact with the inner cylindrical
surface 26 of the cannula 20. When the body 76, 106 is deformed, it
exerts an outward force against the surface 26 to frictionally hold
the retractor in its selected position.
The preferred components provided by this invention are configured
so that multiple tools and instruments can be accepted and
manipulated within the working channel 25 of the cannula 20. The
components are also configured so that more than one surgeon may
manipulate instruments through the working channel 25 of the
cannula 20 at one time. For example, one surgeon may be
manipulating the retractor while another surgeon is drilling into a
bone. The curvature of the body 76, 106 of the retractors 70, 100
provides more working space and increases visibility. Another
feature is that the long axis of the component can be placed in the
working channel 25 while a bend in the handle portion keeps hands
away from the channel 25 so that more than one surgeon can work in
the channel 25 and more tools can be placed in the channel 25. The
retractors shown in FIGS. 4-8 each comprise an arm 71, 101 attached
to the proximal first end 77, 107 of the body 76, 106. Preferably,
as shown in FIGS. 4-8, the arm 71, 101 is at an angle .alpha. which
is less than 180 degrees from the longitudinal axis of the length L
of the body 76. Most preferably, the angle .alpha. is about 90
degrees so that the arm 71, 101 is substantially perpendicular to
the length L of the body 76, 106. Preferably, the arm 71, 101' has
a gripping surface 72, 102 to facilitate manipulation of the
retractor 70, 100.
The present invention also provides tissue dilators usable with the
device 10. Any dilator which is insertable into the working channel
25 of the cannula 20 is contemplated; however, a preferred dilator
provided by this invention is depicted in FIG. 9. A dilator 130
preferably includes a hollow sleeve 135 defining a channel 131. The
channel 131 allows the dilator 130 to be placed over a guidewire
(not shown) or other dilators. The hollow sleeve 135 has a working
end 136 defining a first opening 132 in communication with the
channel 131 and an opposite end 137 defining a second opening 133.
The working end 136 is tapered to a tapered tip 138 to
atraumatically displace tissue. Preferably, a gripping portion 140
is provided on the outer surface 141 of the sleeve 135 adjacent the
opposite end 137. In one embodiment, the gripping portion 140 is
defined by a plurality of circumferential grooves 142 defined in
the outer surface 141. The grooves 142 are configured for manual
gripping of the dilator 130 to manipulate the dilator 130 through
tissue. Preferably, the grooves 142 are partially cylindrical. In
the embodiment shown in FIG. 9, the gripping portion 140 includes a
number of circumferential flats 143 each of the circumferential
grooves 142. The grooves 142 have a first width W.sub.1 along the
length of the sleeve 135 and the flats 143 have a second width
W.sub.2 146 along the length. Preferably, the first and second
widths W.sub.1 and W.sub.2 are substantially equal.
The present invention has application to a wide range of surgical
procedures, and particularly spinal procedures such as laminotomy,
laminectomy, foramenotomy, facetectomy and discectomy. Prior
surgical techniques for each of these procedures has evolved from a
grossly invasive open surgeries to the minimally invasive
techniques represented by the patents of Kambin and Shapiro.
However, in each of these minimally invasive techniques, multiple
entries into the patient is required. Moreover, most of the prior
minimally invasive techniques are readily adapted only for a
posterolateral approach to the spine. The devices and instruments
of the present invention have application in an inventive surgical
technique that permits each of these several types of surgical
procedures to be performed via a single working channel. This
invention can also be used from any approach and in other regions
besides the spine.
The steps of a spinal surgical procedure in accordance with one
aspect of the present invention are depicted in FIG. 10. As can be
readily seen from each of the depicted steps (a)-(i), the present
embodiment of the invention permits a substantially mid-line or
medial posterior approach to the spine. Of course, it is understood
that many of the following surgical steps can be performed from
other approaches to the spine, such as posterolateral and anterior.
In a first step of the technique, a guidewire 150 can be advanced
through the skin and tissue into the laminae M of a vertebral body
V. Preferably, a small incision is made in the skin to facilitate
penetration of the guidewire through the skin. In addition, most
preferably the guidewire, which may be a K-wire, is inserted under
radiographic or image guided control to verify its proper
positioning within the laminae L of the vertebra V. It is, of
course, understood that the guidewire 150 can be positioned at
virtually any location in the spine and in any portion of a
vertebra V. The positioning of the guidewire is dependent upon the
surgical procedure to be conducted through the working channel
cannula of the present intention. Preferably, the guidewire 150 is
solidly anchored into the vertebral bone, being tapped by a mallet
if necessary.
In subsequent steps of the preferred method, a series of tissue
dilators are advanced over the guidewire 150, as depicted in steps
(b)-(d) in FIG. 10. Alternatively, the dilators can be advanced
through the incision without the aid of a guidewire, followed by
blunt dissection of the underlying tissues. In the specific
illustrated embodiment, a series of successively larger dilators
151, 152 and 153 are concentrically disposed over each other and
over the guidewire 150 and advanced into the body to sequentially
dilate the perispinous soft tissues. Most preferably, the tissue
dilators are of the type shown in FIG. 9 of the present
application. In a specific embodiment, the dilators have
successively larger diameters, ranging from 5 mm, to 9 mm to 12.5
mm for the largest dilator. Other dilator sizes are contemplated
depending upon the anatomical approach and upon the desired size of
the working channel.
In the next step of the illustrated technique, the working channel
cannula 20 is advanced over the largest dilator 153, as shown in
step (e), and the dilators and guidewire 150 are removed, as shown
in step (f). Preferably, the working channel cannula 20 has an
inner diameter D.sub.I of 12.7 mm so that it can be easily advanced
over the 12.5 mm outer diameter of the large dilator 153. Larger
working channel cannulas are contemplated depending upon the
anatomical region and surgical procedure.
With the cannula 20 in position, a working channel is formed
between the skin of the patient to a working space adjacent the
spine. It is understood that the length of the cannula 20 is
determined by the particular surgical operation being performed and
the anatomy surrounding the working space. For instance, in the
lumbar spine the distance between the laminae M of a vertebra V to
the skin of the patient requires a longer cannula 20 than a similar
procedure performed in the cervical spine where the vertebral body
is closer to the skin. In one specific embodiment in which the
cannula 20 is used in a lumbar discectomy procedure, the cannula
has a length of 87 mm, although generally only about half of the
length of the cannula will be situated within the patient during
the procedure.
In accordance with the present surgical technique, the working
channel cannula 20 is at least initially only supported by the soft
tissue and skin of the patient. Thus, in one aspect of the
preferred embodiment, the cannula 20 can include a mounting bracket
27 affixed to the outer surface of the cannula (FIG. 10(f), FIG.
11). This mounting bracket 27 can be fastened to a flexible support
arm 160, which can be of known design. Preferably, the flexible
support arm 160 is engaged to the bracket 27 by way of a bolt and
wing nut 161, as shown in FIG. 10 (i) and in more detail in FIG.
11, although other fasteners are also contemplated. This flexible
arm 160 can be mounted on the surgical table and can be readily
adjusted into a fixed position to provide firm support for the
cannula 20. The flexible arm 160 is preferred so that it can be
contoured as required to stay clear of the surgical site and to
allow the surgeons adequate room to manipulate the variety of tools
that would be used throughout the procedure.
Returning to FIG. 10, once the cannula 20 is seated within the
patient, the fixture 30 can be engaged over the proximal end of the
cannula 20. The fixture 30, as shown in FIGS. 2 and 3 and as
described above, provides an optics bore 60 for supporting an
elongated viewing element, such as element 50 shown in step h. In
accordance with the invention, the viewing element 50 is advanced
into the fixture 30 and supported by the optics bore 60 (FIG. 2).
In one specific embodiment, the element 50 is most preferably a
fiber optic scope, although a rod lens scope or other viewing
scopes may be utilized. In the final step (i) of the procedure
shown in FIG. 10, the flexible arm 160 is mounted to the bracket 27
to support the cannula 20 which in turn supports the optical
viewing element 50. This final position of step (i) in FIG. 10 is
shown in more detail in FIG. 11. The viewing element 50 can be of a
variety of types, including a rigid endoscope or a flexible and
steerable scope. With the viewing element or scope 50 supported by
the fixture 30 the surgeon can directly visualize the area beneath
the working channel 25 of the cannula 20. The surgeon can freely
manipulate the viewing element 50 within the working channel 25 or
beyond the distal end of the cannula into the working space. In the
case of a steerable tip scope, the second end 52 of the viewing
element 50, which carries the lens 55, can be manipulated to
different positions, such as shown in FIG. 11. With virtually any
type of viewing element, the manipulation and positioning of the
scope is not limited by the working channel 25, in contrast to
prior systems.
Preferably, the positioning capability provided by the fixture 30
is utilized to allow extension of the lens 55 into the working
space or retraction back within the cannula 20, as depicted by the
arrows T in FIG. 1. Also the fixture preferably accommodates
rotation of the element 50 about its own axis (arrows R in FIG. 1)
to vary the viewing angle provided by the angled lens 55, or
rotation of the entire viewing element 50 about the cannula 20 and
around the circumference of the working channel 25, as shown by the
arrows N in FIG. 1. In this manner, the surgeon is provided with a
complete and unrestricted view of the entire working space beneath
the working channel 25. In instances when the fixture 30 is rotated
about the cannula 20, the viewing orientation of the optics (i.e.,
left-right and up-down) is not altered so the surgeon's view of the
procedure and surrounding anatomy is not disturbed..
Another advantage provided by the single working channel cannula 20
of the present invention, is that the cannula can be readily
positioned over an appropriate target tissue or bone, to thereby
move the working space as necessary for the surgical procedure. In
other words, since the working channel cannula 20 is freely
situated within the patient's skin and tissue, it can be
manipulated so that the working space beneath the cannula 20 is
more appropriately centered over the target region of the spine.
Repositioning of the cannula 20 can be performed under fluoroscopic
guidance. Alternatively, the cannula may be fitted with position
sensing devices, such as LEDs, to be guided stereotactically. As
the cannula is being repositioned, the surgeon can also directly
visualize the spine through the viewing element 50.
Once the position of the cannula 20 is established and a working
space is oriented over the proper target tissue, a variety of tools
and instruments can be extended through the working channel 25 to
accomplish the particular surgical procedure to be performed. For
instance, in the case of a laminotomy, laminectomy, foramenotomy or
facetectomy, a variety of rongeurs, curettes, and trephines can be
extended through the working channel opening 35 (see FIG. 2) and
through the working channel 25 of the cannula 20 (see FIG. 11) into
the working space. It is understood that these various tools and
instruments are designed to fit through the working channel. For
instance, in one specific embodiment, the working channel 25
through the cannula 20 can have a maximum diameter d.sub.2 of 12.7
mm. However, with the viewing element 50 extending into the working
channel 25, the effective diameter is about 8 mm in the specific
illustrated embodiment, although adequate space is provided within
the working channel 25 around the viewing element 50 to allow a
wide range of movement of the tool or instrument within the working
channel. The present invention is not limited to particular sizes
for the working channel and effective diameter, since the
dimensions of the components will depend upon the anatomy of the
surgical site and the type of procedure being performed.
Preferably, each of the tools and instruments used with the working
channel cannula 20 are designed to minimize obstruction of the
surgeon's visualization of and access to the working space at the
distal end of the working channel cannula. Likewise, the
instruments and tools are designed so that their actuating ends
which are manipulated by the surgeon are displaced from the working
channel cannula 20. One such example is the tissue retractor shown
in FIGS. 4-8. With these retractors, the handles that are manually
gripped by the surgeon are offset at about a 90 degree angle
relative to the longitudinal axis of the tool itself.
In accordance with once aspect of the present invention, the
surgical procedures conducted through the working channel cannula
20 and within the working space at the distal end of the cannula
are performed "dry"--that is, without the use of irrigation fluid.
In prior surgical techniques, the working space at the surgical
site is fluid filled to maintain the working space and to assist in
the use of the visualization optics. However, in these prior
systems the visualization optics were fixed within the endoscope.
In contrast, the device 10 of the present invention allows a wide
range of movement for the viewing element 50 so that the lens 55
can be retracted completely within the working channel 25 of the
cannula 20 to protect it from contact with the perispinous tissue
or blood that may be generated at the surgical site.
Moreover, since the viewing element 50 is removable and
replaceable, the element 50 can be completely removed from the
fixture 30 so that the lens 55 can be cleaned, after which the
viewing element 50 can be reinserted into the fixture and advanced
back to the working space. Under these circumstances, then, the
need for irrigation is less critical. This feature can be of
particular value when cutting operations are being performed by a
power drill. It has been found in prior surgical procedures that
the use of a power drill in a fluid environment can cause
turbulence or cavitation of the fluid. This turbulence can
completely shroud the surgeon's view of the surgical site at least
while the drill is being operated. With the present invention, the
dry environment allows continuous viewing of the operation of the
power drill so that the surgeon can quickly and efficiently perform
the necessary cutting procedures.
While the present invention permits the surgeon to conduct surgical
procedures in the working space under a dry environment:,
irrigation may be provided separately through the working channel
25. Alternatively, the viewing device 50 itself may include a tube
54 supported by the fitting 53 through which modest amounts of
fluid can be provided to keep the visualization space clear. In
addition, during a discectomy, aspiration of the excised tissue is
preferred, and irrigation will frequently assist in rapid removal
of this tissue. Thus, separate irrigation and aspiration elements
can also be inserted through the working channel 25 as required by
the procedure.
As necessary, aspiration can be conducted directly through the
working channel 25 of the cannula 20. In one specific embodiment,
an aspiration cap 165 is provided as shown in FIGS. 11 and 12. The
cap 165 includes a body 166 which defines a mating bore 167 having
an inner diameter d.sub.b larger than the outer diameter D.sub.h of
the housing 31 of fitting 30. A tool opening 168 is provided in
communication with the mating bore 167. When the aspiration cap 165
is mounted over the housing 31, as shown in FIG. 11, the tool
opening 168 communicates directly with the upper bore 41 and
provides the same entry capabilities as the working channel opening
35 of the housing 31. The aspiration cap 165 is also provided with
a tube receiver bore 169 which intersects the mating bore 167. The
receiver bore 169 is configured to receive an aspiration tube
through which a vacuum or suction is applied. In certain instances,
the tool opening 168 may be covered while suction is applied
through the tool receiver bore 169 and mating bore 167, and
ultimately through the working channel 25. Covering the opening 168
can optimize the aspiration effect through the working channel.
Returning again to the surgical technique of one embodiment of the
present invention, once the working channel cannula 20 and the
optics 50 are in position, as depicted in FIG. 10 step (i) and FIG.
11, the paraspinous tissue can be reflected using instruments as
described above, and a laminectomy performed using various
rongeurs, curettes and drills. As necessary, the cannula 20 can be
angled to allow a greater region of bone removal, which may be
necessary for access to other portions of the spinal anatomy. In
some instances, access to the spinal canal and the posterior medial
aspects of the disc annulus may require cutting a portion of the
vertebral bone that is greater than the inner diameter of the
working channel 25. Thus, some manipulation of the cannula 20 may
be necessary to permit removal of a greater portion of bone. In
other operations, multi-level laminectomies or foramenotomies may
be necessary. In this instance, these multi-level procedures can be
conducted by sequentially inserting the working channel cannula 20
through several small cutaneous incisions along the spinal
mid-line. Alternatively, several working channel cannulas 20 can be
placed at each of the small cutaneous incisions to perform th e
multi-level bone removal procedures.
Again, in accordance with the preferred illustrated surgical
technique, an opening is cut into the laminae M of the vertebra V
providing direct visual access to the spinal canal itself. As
necessary, tissue surrounding the spinal nerve root can be removed
utilizing micro surgical knives and curettes. Once the spinal nerve
root is exposed, a retractor, such as the retractors shown in FIGS.
4-8, can be used to gently move and hold the nerve root outside the
working space. In one important aspect of the two retractors 70,
100, the portion of the retractor passing through the working
channel 25 generally conforms to the inner surface of the cannula
20 so that the working channel 25 is not disrupted by the retractor
tool. Specifically, the effective diameter within the working
channel 25 is reduced only by the thickness of the curved plates
84, 114 of the retractors 70, 100. In one specific embodiment, this
thickness is about 0.3 mm, so it can be seen that the tissue
retractors do not significantly reduce the space available in the
working channel 25 for insertion of other tools and
instruments.
With the tissue retractor in place within the working channel 25,
bone within the spinal canal, such as may occur in a burst
fracture, can be removed with a curette or a high speed drill.
Alternatively, the fractured bone may be impacted back into the
vertebral body with a bone impactor. At this point, if the spinal
procedure to be performed is the removal of epidural spinal tumors,
the tumors can be resected utilizing various micro-surgical
instruments. In other procedures, the dura may be opened and the
intradural pathology may be approached with micro-surgical
instruments passing through the working channel cannula 20. In
accordance with the specific illustrated technique, with the nerve
root retracted posterior medial disc herniations can be readily
excised directly at the site of the herniation.
One important feature of the present invention is achieved by the
large diameter of the working channel 25 in the cannula 20. This
large diameter allows the surgeon or surgeons conducting the
surgical procedure to introduce a plurality of instruments or tools
into the working space. For example, as described above, a tissue
retractor and discectomy instruments can be simultaneously extended
through the working channel. In that illustrated embodiment, the
discectomy instruments could include a trephine for boring a hole
through the disc annulus and a powered tissue cutter for excising
the herniated disc nucleus. Likewise, the present invention
contemplates the simultaneous introduction of other types of
instruments or tools as may be dictated by the particular surgical
procedure to be performed. For example, an appropriately sized
curette and a rongeur may be simultaneously extended through the
working channel into the working space. Since all operations being
conducted in the working space are under direct visualization
through the viewing element 50, the surgeon can readily manipulate
each of the instruments to perform tissue removal and bone cutting
operations, without having to remove one tool and insert the other.
In addition, since the surgical procedures can be conducted without
the necessity of irrigation fluid, the surgeon has a clear view
through the working space of the target tissue. Furthermore,
aspects of the invention which permit a wide range of motion to the
viewing element 50 allow the surgeon to clearly visualize the
target tissue and clearly observe the surgical procedures being
conducted in the working space.
The surgeon can capitalize on the same advantages in conducting a
wide range of procedures at a wide range of locations in the human
body. For example, facetectomies could be conducted through the
working channel by simply orienting the working channel cannula 20
over the particular facet joints. The insertion of vertebral
fixation elements can also be accomplished through the device 10.
In this type of procedure, an incision can be made in the skin
posterior to the location of the vertebra at which the fixation
element is to be implanted. Implementing the steps shown in FIG.
10, the cannula 20 can be positioned through the incision and
tissue directly above the particular location on the vertebra to be
instrumented. With the optics extending through the working
channel, an insertion tool holding the vertebral fixation element
can be projected through the cannula 20 and manipulated at the
vertebra. In one specific embodiment, the fixation element can be a
bone screw. The working channel 25 has a diameter that is large
enough to accept most bone screws and their associated insertion
tools. In many instances, the location of the bone screw within the
vertebra is critical, so identification of the position of the
cannula 20 over the bony site is necessary. As mentioned above,
this position can be verified fluoroscopically or using
stereotactic technology.
In many prior procedures, cannulated bone screws are driven into
the vertebra along K-wires. The present invention eliminates the
need for the K-wire and for a cannulated screw. The working channel
itself can effectively operate as a positioning guide, once the
cannula 20 is properly oriented with respect to the vertebra.
Moreover, the device 10 allows insertion of the bone screw into the
vertebra to be conducted under direct vision. The surgeon can then
readily verify that the screw is passing into the vertebra
properly. This can be particularly important for bone screws being
threaded into the pedicle of a vertebra. The working channel
cannula 20 can be used to directly insert a self-tapping bone screw
into the pedicle, or can accept a variety of tools to prepare a
threaded bore within the pedicle to receive a bone screw.
The device 10 can also be used to prepare a site for fusion of two
adjacent vertebrae, and for implantation of a fusion device or
material. For example, in one surgical technique, an incision can
be made in the skin posterior to a particular disc space to be
fused. The incision can be made anteriorly, posteriorly or
posterior laterally. If the incision is made anteriorly for
anterior insertion of the working channel, it is anticipated that
care will be taken to retract tissues, muscle and organs that may
follow the path of the incision to the disc space. However, the
device 10 of the present invention allows this tissue retraction to
occur under direct vision so that the surgeon can easily and
accurately guide the cannula 20 to the disc space without fear of
injury to the surrounding tissue. As the tissue beneath the skin is
successively excised or retracted, the working channel cannula 20
can be progressively advanced toward the anticipated working space
adjacent the vertebral disc. Again under direct vision, the disc
space can be prepared for implantation of fusion materials or a
fusion device. Typically, this preparation includes preparing an
opening in the disc annulus, and excising all or part of the disc
nucleus through this opening.
In subsequent steps, a bore is cut through the disc annulus and
into the endplates of the adjacent vertebrae. A fusion device, such
as a bone dowel, a push-in implant or a threaded implant can then
be advanced through the working channel of device 10 and into the
prepared bore at the subject disc space. In some instances, the
preparatory steps involve preparing the vertebral endplates by
reducing the endplates to bleeding bone. In this instance, some
aspiration and irrigation may be beneficial. All of these
procedures can be conducted by tools and instruments extending
through the working channel cannula 20 and under direct vision from
the viewing element 50.
In some instances, graft material is simply placed within the
prepared bore. This graft material can also be passed through the
working channel cannula 20 into the disc space location. In other
procedures, graft material or bone chips are positioned across
posterior aspects of the spine. Again, this procedure can be
conducted through the working channel cannula particularly given
the capability of the cannula to be moved to different angles from
a single incision site in the skin.
The present invention provides instruments and techniques for
conducting a variety of surgical procedures. In the illustrated
embodiments, these procedures are conducted on the spine. However,
the same devices and techniques can be used at other places in the
body. For example, an appropriately sized working channel device 10
can be used to remove lesions in the brain. The present invention
has particular value for percutaneous procedures where minimal
invasion into the patient is desirable and where accurate
manipulation of tools and instruments at the surgical site is
required. While the preferred embodiments illustrated above concern
spinal procedures, the present invention and techniques can be used
throughout the body, such as in the cranial cavity, the pituitary
regions, the gastrointestinal tract, etc. The ability to reposition
the viewing optics as required to visualize the surgical site
allows for much greater accuracy and control of the surgical
procedure. The present invention allows the use of but a single
entry into the patient which greatly reduces the risk associated
with open surgery or multiple invasions through the patient's
skin.
While the invention has been illustrated and described in detail in
the drawings and foregoing description, the same is to be
considered as illustrative and not restrictive in character, it
being understood that only the preferred embodiment has been shown
and described and that all changes and modifications that come
within the spirit of the invention are desired to be protected.
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